Alzheimer's Study Being Performed in Norwalk

By Bart A. Sloan, MD

Research Center for Clinical Studies, Inc.

Today in the U.S., more than five million people are living with mild-to-moderate Alzheimer’s disease (AD).[1] As we live longer, rates of AD have grown dramatically and the disease is now cited as the third leading cause of death in the United States. Alzheimer’s disease affects more than five million individuals in the United States and is now the third leading cause of death in the U.S.[2] [3]

Encouraging strides are being made toward early intervention and preventative therapies in AD. However, at the same time, AD clinical researchers cannot - and will not - leave anyone behind as the research progresses. We are well aware that new therapies are desperately needed for people currently diagnosed with AD. No new drug has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of AD since 2003 and advances in treatment options for patients already living with mild-to-moderate AD remain a critical need.

Alzheimer’s disease, the most common type of dementia, develops when nerve cells in the brain no longer function normally, causing a change in one’s memory. Mild-to-moderate AD signals the stage at which the decline in cognitive function becomes apparent to friends and family. Symptoms of mild-to-moderate AD include everything from increased difficulty performing simple tasks such as paying bills, to forgetfulness about one’s own personal history and becoming moody and withdrawn in social situations. For those who have ever loved or cared for someone with AD, it becomes apparent that caring for an AD patient often becomes a full time job, impacting quality of life not only for the patient but for the caregiver as well. For caregivers, the gradual but permanent decline in their loved one’s mental and physical capabilities often takes a deep emotional and psychological toll.

Researchers at Research Center for Clinical Studies and other clinical research organizations are committed to providing patients with access to studies that will help advance research on Alzheimer’s at all stages of the disease.

To push this initiative forward, Research Center for Clinical Studies is participating in the NOBLE Study, a clinical trial of an investigational medication that uses a neuroprotectant approach that has been used successful in many central nervous system disorders including stroke and Parkinson’s disease. The study will focus on evaluating a medication specifically for those with mild-to-moderate AD.

The NOBLE study is one example of ways patients and their families can play a critical role in helping researchers find new treatment approaches to improve the lives of those impacted by Alzheimer’s disease, and we look forward to working with the Fairfield County community to meet this pressing healthcare challenge.

Interested in learning more?

Those interested in learning more should contact Kinjalben Patel at 203- 838-0070.

NOBLE is a Phase-2 multi-center, randomized, double blind, placebo-controlled, parallel group study. The duration of treatment is about 14 months.

Participants will be screened for eligibility and must be:

• Aged 55-85 years old with mild to moderate Alzheimer’s Disease

· Are stable on donepezil (Aricept®) or rivastigmine (Exelon® Patch) treatment

• Living in the community (not a nursing home)
• Have a study partner that has regular contact and who will attend study visits
• Weigh no more than 220 pounds

More information on the NOBLE Study can also be found at http://www.noblestudy.org/